癌研連線CancerLink
進行中（不再收案） NCT05059262

Vimseltinib 用於腱鞘巨細胞瘤的研究

膽道癌Phase IIIIII 期IV 期

這是一項多中心第三期臨床研究，旨在評估一種名為 vimseltinib 的研究性藥物用於治療腱鞘巨細胞瘤（TGCT）的療效，適用於無法進行手術切除腫瘤的情況。 該研究分為兩部分。在第一部分中，符合條件的研究參與者將被分配接受 vimseltinib 或匹配的安慰劑治療 24 週。

適應症：Tenosynovial Giant Cell Tumor、Pigmented Villonodular Synovitis、Giant Cell Tumor of Tendon Sheath、Tenosynovial Giant Cell Tumor, Diffuse、Tenosynovial Giant Cell Tumor, Localized

收案條件

納入條件

  • Patients ≥18 years of age
  • TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
  • Symptomatic disease as defined as at least moderate pain or at least moderate stiffness (defined as a score of 4 or more, with 10 describing the worst condition) within the screening period and documented in the medical record
  • Participants should complete 14 consecutive days of questionnaires during the screening period and must meet minimum requirements as outlined in study protocol
  • Must have stable analgesic regimen, as judged by the investigator, for at least 2 weeks prior to first dose of study drug
  • Must have measurable disease, as per RECIST Version 1.1, with at least one lesion having a minimum size of 2cm
  • Adequate organ and bone marrow function
  • If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
  • Must provide signed consent to participate in the study and is willing to comply with study-specific procedures
  • Willing and able to complete the patient-reported outcome (PRO) assessments on an electronic device

排除條件

  • Previous use of systemic therapy (investigational or approved) targeting colony-stimulating factor 1 (CSF1) or colony-stimulating factor 1 receptor (CSF1R); previous therapy with imatinib and nilotinib is allowed
  • Received therapy for TGCT, including investigational therapy during the screening period. Participated in a non-TGCT investigational drug study within 30 days of screening.
  • Known metastatic TGCT or other active cancer that requires concurrent treatment (exceptions will be considered on a case-by-case basis)
  • QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT syndrome
  • Concurrent treatment with any study-prohibited medications
  • Major surgery within 14 days of the first dose of study drug
  • Any clinically significant comorbidities
  • Active liver or biliary disease including nonalcoholic steatohepatitis (NASH) or cirrhosis
  • Malabsorption syndrome or other illness that could affect oral absorption
  • Known active human immunodeficiency virus (HIV), acute or chronic hepatitis B, acute or chronic hepatitis C, or known active mycobacterium tuberculosis infection
  • If female, the participant is pregnant or breastfeeding
  • Known allergy or hypersensitivity to any component of the study drug
  • Contraindication to MRI

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。